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Development of composition and technology
Development of the composition and production technology of a medicinal product is a multi-stage process that includes research, testing and optimization of the formula, as well as the development of the manufacturing process.
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1.
Research and testing
The first step in drug formulation development is research and testing of the ingredients that will be used in the formula. At this stage, tests are carried out to find out which ingredients work best together and what concentration of each ingredient will be optimal.
2.
Formula optimization
The next step is to optimize the composition of the medicinal product based on the results of research and testing. This considers factors such as the effectiveness of the drug, the safety of its use, stability in storage and transportation, as well as the possibility of mass production.
3.
Development of production technology
After optimizing the formula, a drug production technology is developed. At this stage, all stages of production are determined, starting with the receipt of raw materials and ending with the packaging and packaging of the finished product. Each stage of the production technology must be optimized as much as possible in order for the production to be efficient and meet high quality standards.
4.
Quality control
After the composition and production technology of the medicinal product have been developed, a quality control system is introduced. All stages of production are carefully controlled and checked for compliance with quality standards. This includes analyzes of raw materials, intermediate products and finished product, as well as checking the conformity of production technology and compliance with expiration dates.
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Registration
Development of registration dossier, registration, licensing and certification
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Clinical and preclinical studies
Organization and support of preclinical and clinical studies
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OLFARM LLC is an independent accredited laboratory and research center. The scope of accreditation of the testing laboratory includes a wide range of physicochemical, microbiological, virological and biological methods.
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